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YAZ Premenstrual Dysphoric Disorder (PMDD) in China

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00824187
First received: January 15, 2009
Last updated: March 21, 2013
Last verified: March 2013
History of Changes

January 15, 2009
March 21, 2013
January 2009
January 2011   (final data collection date for primary outcome measure)
The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles [ Time Frame: 3 cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]
The primary efficacy variable is the difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days of the 3rd treatment cycle to average scores from the last 5 days of the 2 run in cycles [ Time Frame: 3 cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00824187 on ClinicalTrials.gov Archive Site
  • The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase [ Time Frame: 3 cylces ] [ Designated as safety issue: No ]
  • Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Assessment of CGI scores [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Descriptive statistics for total DRSP scale scores for each of the 2 run cycles, each of the 3 treatment cycles, and the average of the 3 treatment cycles [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Difference in DRSP scale scores for the 3 functional impairment items, comparing the average of daily scores from the 3rd treatment cycle to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cylces ] [ Designated as safety issue: No ]
  • Assessment of CGI scores [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD)

The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Premenstrual Dysphoric Disorder ( PMDD)
  • Drug: EE20/DRSP(YAZ, BAY86-5300)
    20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
  • Drug: Placebo
    Inert tablet
  • Experimental: Arm 1
    Intervention: Drug: EE20/DRSP(YAZ, BAY86-5300)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

Exclusion Criteria:

  • Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
  • Use of sleeping medication (including melatonin) for more than 3 days per month.
  • Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
  • Obesity (body mass index or BMI > 30 kg/m2)
  • Hypersensitivity to any ingredient of the study drug
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00824187
91771, 311962
No
Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP